1. 86% CRc in newly diagnosed NPM1-m AML patients observed. 2. Ziftomenib combined with venetoclax/azacitidine has favorable safety profile. 3. Ongoing trials for ziftomenib in front-line and R/R AML settings. 4. Kura will host an investor event discussing ziftomenib advancements. 5. Encouraging response rates noted for relapsed/refractory AML patients.
FAQ
Why Bullish?
The strong clinical data on ziftomenib enhances Kura's growth potential, similar to other successful launches in oncology.
How important is it?
The positive trial results and safety profile make ziftomenib a competitive treatment option in AML, impacting KURA's stock favorably.
Why Long Term?
As ongoing trials mature and regulatory approvals progress, ziftomenib's role in AML treatments will likely solidify, enhancing Kura's market position.
Kura Oncology and Kyowa Kirin Announce Promising Data for KOMZIFTI™ (Ziftomenib) in AML Treatment
On December 8, 2025, Kura Oncology, Inc. (Nasdaq: KURA) and Kyowa Kirin Co., Ltd. presented new findings demonstrating the encouraging safety and efficacy of KOMZIFTI (ziftomenib) in combination with venetoclax and azacitidine for treating acute myeloid leukemia (AML). The results, shared during the 67th Annual Meeting of the American Society of Hematology (ASH 2025), highlight compelling clinical activity in both newly diagnosed and relapsed/refractory AML patients.
Key Findings from the KOMET-007 Trial
The ongoing KOMET-007 Phase 1a/1b trial assessed patients with NPM1 mutations (NPM1-m) and KMT2A rearrangements (KMT2A-r). Key takeaways from the data include:
- 86% of newly diagnosed NPM1-m AML patients achieved composite complete remission (CRc).
- 73% reached complete remission (CR), with 68% achieving molecular minimal residual disease (MRD) negativity.
- For relapsed/refractory NPM1-m AML, an overall response rate (ORR) of 65% was observed.
- In R/R KMT2A-r AML, the ORR was 41%, significantly increasing to 70% among venetoclax-naïve patients.
Clinical Implications and Tolerability
According to Dr. Gail J. Roboz, a leading hematologist/oncologist at Weill Cornell Medicine, “The addition of ziftomenib to venetoclax and azacitidine has shown promising clinical activity.” She emphasized that while the median duration of response and overall survival remain under evaluation, the integration of ziftomenib has been well tolerated, without an increase in toxicity levels.
This favorable safety profile allows for the combination's potential integration into treatment regimens for AML, particularly in front-line and relapsed/refractory scenarios.
Details on Treatment Efficacy
The trial's findings included:
- In newly diagnosed patients, median follow-up was 26.1 weeks, with rates of treatment continuation and follow-up showing that 68% remained alive as of the data cutoff.
- In the relapsed/refractory patient cohort, median overall survival was noted at 54.9 weeks.
- No significant ziftomenib-related QTc prolongation was reported, further supporting its safety profile.
Future Directions for Ziftomenib
As Kura continues its pivotal KOMET-017 trials, the results reinforce the belief that ziftomenib could play a foundational role in AML treatment. "These compelling data reinforce our conviction that ziftomenib has the potential to become a foundational, best-in-class menin inhibitor for patients with AML," stated Dr. Mollie Leoni, Chief Medical Officer at Kura Oncology.
Investor Event and Resources
Kura Oncology is set to host a virtual investor event later today at 12:30 p.m. ET / 9:30 a.m. PT. Attendees will include Kura management and prominent oncologists discussing these findings. Interested parties can access the webcast on Kura’s official website under the Investors tab.
About KOMZIFTI™ (Ziftomenib)
KOMZIFTI (ziftomenib) is the first once-daily oral menin inhibitor approved for adult patients with relapsed or refractory AML harboring a susceptible NPM1 mutation. It is specifically designed for those who lack satisfactory alternative treatment options and is currently commercially available in the United States.